Intestinal mucosal immune responses to novel oral poliovirus vaccine type 2 in newborns
Preprint
Abstract
Background: Approximately 1.2 billion doses of novel type 2 oral polio vaccine (nOPV2) have been administered in response to circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks since 2021. Although infants are eligible to receive the vaccine from birth, the induction of intestinal mucosal immunity by nOPV2 in newborns has not been directly evaluated. Methods: In a randomized, placebo-controlled, phase 2 clinical trial in Bangladesh (2020–2021), 215 healthy newborns received two doses of either nOPV2 (n=110) or placebo (sucrose; n=105), at birth (0-3 days) and 4 weeks later. Intestinal mucosal immunity was assessed by measuring poliovirus type 2 (PV2)-specific neutralizing activity and immunoglobulin (Ig)A levels in stool collected biweekly from birth to 8-weeks. Results: Newborns vaccinated with two doses of nOPV2 had strong intestinal mucosal immune responses that differed significantly from the placebo group (pTrial registration number NCT04693286Keywords
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